Welcome to
UNIFIED
Unifying Framework for Patient-Centred Clinical-Study Endpoints Derived from Digital Health Technologies
Led by Erasmus University Rotterdam and Pfizer, with 38 other global partners
Funded by the EU under the Innovative Health Initiative Joint Undertaking
5-year project running from November 2025 to October 2030
Ambition
UNIFIED will enhance patient-centred care by ensuring healthcare decisions are patient-centred and reflect true value to patients, thereby improving patient outcomes, and ensuring healthcare's long-term effectiveness and economic sustainability.
The project will build an evidence-based framework and consensus-based recommendations, providing structured guideline, protocols, and standards to:
1
Integrate patient preference information (PPI), clinical outcome assessments (COAs), and digital health technology (DHT)-derived measures into healthcare decisions
2
Determine minimal (clinically) important difference (MCID/MID) in a clinical-study endpoint from the patient perspective
VISION
Patient-centred collaboration
Together, we create a harmonised framework that integrates patient-centred endpoints into healthcare decisions, supports evidence-based recommendations, enables holistic evaluation of therapies, and ensures adoption across all relevant stakeholder groups. Our vision is supported by a diverse network of leaders in DHT measures, COA, PPI, and AI, as well as clinical guidelines organisations, key health stakeholders, and other relevant initiatives. Central to this collaboration is the European Patients’ Forum, a core project partner, which ensures that patient perspectives are integrated throughout the project from design to implementation and dissemination.
Create a harmonised, internationally aligned approach to integrating PPI, COA, and DHT data in the development of patient-centred clinical-study endpoints
Deliver the UNIFIED Framework with clear guidelines, standards & consensus-based recommendations
Integrate PPI, COAs, DHT measures into healthcare decisions using robust Artificial Intelligence technologies
Enable holistic evaluation of therapies: clinical, economic, and patient value
Ensure adoption of the framework and recommendations by all key stakeholders: patients, clinicians, regulators, HTA bodies, payers, and industry
KEY OBJECTIVES
To realise its vision, UNIFIED will deliver 7 SMART objectives, meaning goals that are Specific, Measurable, Achievable, Relevant, and Time-bound. Each objective is paired with clear Key Performance Indicators to ensure transparent progress tracking, stakeholder alignment, and lasting impact across healthcare, policy, and research domains.
UNIFIED Framework
A comprehensive framework will be developed to integrate PPI, COAs, and DHT measures, and to determine MCID/MID in a patient-centred, DHT-derived clinical-study endpoint. This framework’s robust view of patient-centred endpoints in clinical studies involving chronic disease patients will support R&D, clinical, regulatory, HTA, and reimbursement decisions.
KPIs: Endorsed by ≥4 targeted stakeholder groups; adopted in ≥5 stakeholder institutions during the project.
Consensus-Based Recommendations
Consensus-based recommendations will be developed, tested, and validated for the use of the UNIFIED Framework in R&D, clinical, regulatory, HTA, and reimbursement decision-making, aligned with existing policies and ensuring inclusivity.
KPIs: Endorsed by ≥2 regulatory agencies; adopted by ≥2 HTA/payer bodies during the project.
Common Taxonomy
A comprehensive taxonomy will be developed and a linkable scaling between PPIs, COAs, and DHT measures will be established, with instructional materials supporting application across use cases in five medical domains. This will help determine how patient preferences can enhance the understanding of patient-reported outcomes, the correlation (or lack thereof) between patient-reported and sensor-based measurements, and whether digital endpoints reflect patient preferences. We will extend and advance existing core outcome sets and analyse similarities and differences in the use cases, gathering evidence on the feasibility of pooling PPI, COAs, and DHT measures into a single patient-centric metric.
KPIs: Completed by project end and used by ≥2 medical institutions or research bodies in clinical studies.
Validation in 5 Use Cases
The UNIFIED Framework and recommendations will be tested and validated in use cases in five areas across Europe and Canada: Paediatric Radiation Oncology, Lung Cancer, Parkinson’s Disease, Obesity, and Juvenile Idiopathic Arthritis.
KPIs: Full use cases completed ≥1 year before project end; improved data integration in ≥3 medical domains.
Stakeholder Engagement
We will ensure the UNIFIED Framework’s broad recognition, regulatory endorsement, implementation strategies, and clinical impact by aligning it with existing frameworks and guidance documents and implementing co-creation activities involving patients, caregivers, patient organisations, regulators, HTA/payer bodies, and clinicians.
KPIs: Developed ≥1 adoption activity by regulators, HTA/payer bodies, and patient organisations; created recommendations for updating ≥2 clinical guidelines; collected ongoing feedback from ≥10 stakeholder meetings throughout the project.
Coordination with Initiatives
The UNIFIED Framework will integrate methods and outcomes from relevant national or international research and innovation initiatives to leverage existing knowledge, ensure a head start, and avoid redundancy.
KPIs: Established direct connections with ≥12 relevant ongoing or completed initiatives; provided quarterly updates during the project.
Sustainability & Longevity
A sustainable digital infrastructure will be developed to keep project outputs accessible and enable ongoing post-project research.
KPIs: Created a public digital platform with ≥1,000 unique users in the 6 months post-project; contributed to ≥2 new research initiatives studying patient-centred care.
WORK PACKAGES
UNIFIED is structured into six interlinked Work Packages (WPs), each designed to deliver key components of the project in a coordinated and efficient way. These WPs cover methodology development, real-world validation, stakeholder engagement, dissemination, sustainability, and project management, ensuring that all scientific, operational, and strategic goals are met.
Methodology and Preliminary Recommendations
1
Use Cases
2
UNIFIED Framework and Consensus-Based Recommendations
3
Stakeholder Engagement and Adoption Strategies
4
Sustainability, Dissemination, Exploitation, and Communication
5
Project Management
6
WORK PACKAGES
WP3: Consensus-based recommendations
WP2: Use cases
WP5: Exploitation, dissemination, and communication
WP4: Stakeholder engagement and adoption strategies
WP6: Project management
USE CASES
UNIFIED will validate its framework across five complementary medical use cases, ensuring real-world relevance, diversity, and applicability. These use cases will demonstrate how patient-centred endpoints can be integrated into clinical development, regulatory decision-making, and health technology assessment across varied therapeutic areas.
1 - Paediatric Radiation Oncology
This use case addresses two groups: paediatric oncology patients currently undergoing curative radiotherapy and long-term survivors of childhood cancer who received radiotherapy. For current patients, understanding their preferences for psychoeducational support, alongside COA and DHT-based measures of anxiety, mood, and distress, will help optimise treatment outcomes and reduce long-term health and economic burdens. For long-term survivors, the aim is to improve follow-up care by exploring the lasting physical and psychological impacts of treatment, such as fatigue, neurocognitive issues, and mental health challenges, and incorporating survivor preferences into personalised survivorship care plans. Together, these perspectives span the full treatment journey, enabling more holistic, effective, and sustainable patient-centred care for children affected by cancer.
2 - Lung Cancer
This use case aims to enhance telemedicine communication and data sharing among patients, physicians, and caregivers, enabling seamless teleconsultations between specialists and multidisciplinary teams. Remote, noninvasive DHT monitoring will allow to personalise patients' follow-ups and improve early detection of disease recurrence or progression. Spanning multiple countries, including Italy, Spain, Germany, and Austria, the lung cancer use case leverages both prospective and historical patient data available to UNIFIED. This cross-border expansion allows the consortium to explore how regional healthcare systems variations (e.g., availability of care) impact treatment and patient-centred outcomes, addressing the needs of lung cancer patients. Care for lung cancer patients must be personalised and arrive efficiently at the right time to ensure both survival and quality of life.
3 - Parkinson's Disease
This use case includes one of the most complex neurodegenerative diseases. Given the variability in symptom presentation, we will rely heavily on DHT to track real-time symptom fluctuations and patient-centred outcomes through PPI and COA measures. In the absence of biomarkers, DHTs provide new tools for the objective detection of changes in symptoms and the progression of Parkinson’s disease. They also provide means for the patient to monitor and inform the caregiver better on bothersome symptoms appearing in everyday life.
4 - Obesity
This use case addresses a condition with growing prevalence and economic impact, where stigma makes patient engagement especially important. It explores the use of (interactive) DHT to collect PPI and COA, with attention to reflecting socio-economic diversity. While sustained weight loss is challenging, even modest reductions improve health outcomes. Identifying and integrating effective patient-monitoring tools can support motivation, adherence, disease management, and early complication detection.
5 - Juvenile Idiopathic Arthritis
This use case engages children living with Juvenile Idiopathic Arthritis (JIA) and their caregivers across Canada and Europe, creating a unique dual perspective on disease impact and care. By combining child–parent data, the consortium will examine how family experiences and priorities influence treatment decisions and shape what meaningful improvement looks like in everyday life. Using both prospective and existing registry data, UNIFIED will explore new mechanisms for PPI in paediatric trials, aiming to enhance data quality, completion rates, and the relevance of clinical endpoints. Care for JIA must be personalised and timely to prevent lifelong disability and ensure the best possible quality of life for every child.
We see this as a breakthrough project. By combining the expertise of public and private institutions, we hope to close the gap that patients, clinicians, industry, academics, and policymakers have long faced. It’s ambitious, it’s necessary, and it directly addresses what patients have been seeking.
Prof. Dr. Esther de Bekker-Grob
UNIFIED Public Lead, Professor of Health Economics & Health Preferences, Erasmus University Rotterdam
OUR TEAM
PRESS RELEASE
UNIFIED Launches to Put Patient Voices at the Heart of Healthcare Decisions
Rotterdam, 4 November 2025 – Erasmus University Rotterdam and Pfizer lead UNIFIED (Unifying Framework for Patient-Centred Clinical-study Endpoints Derived from Digital Health Technologies), a five-year, €27 million global public-private partnership funded by the Horizon Europe Innovative Health Initiative Joint Undertaking. The project aims to develop a harmonised, internationally aligned approach, integrating patient-centred clinical-study endpoints to support the full benefit of a therapy to patients.